Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy completely omitting aspirin.

Objective: This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to net clinical adverse events and ischemic events in patients with non-ST segment elevation acute coronary syndrome.

Study design: Open-label, multicentre randomized controlled trial.

Study population: Adult patients presenting with non-ST segment elevation acute coronary syndrome planned for percutaneous coronary intervention.

Intervention: In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI.

Main study parameters/endpoints: The primary net adverse clinical endpoint is defined as the composite of all-cause death, myocardial infarction, stroke and Bleeding Academic Research Consortium type 3 or 5 bleeding at 12 months. The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Adult patients presenting with NSTE-ACS planned for PCI

• Written informed consent

Exclusion Criteria:

• Known allergy or contraindication for aspirin or P2Y12-inhibitors

• Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)

• Overwriting indication for DAPT (e.g. recent PCI or ACS)

• Planned surgical intervention within 12 months of revascularization

• Pregnant or breastfeeding women at time of enrolment

• Participation in another trial with an investigational drug or device (i.e. stent)